FDA Product Code
FDA Product Code JJX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 493 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | 2017-04-04 | Traditional | PDF ↗ |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | 2017-01-12 | Traditional | PDF ↗ |
| K162514 | Multichem A1c | Technopath Manufacturing | 2016-10-26 | Abbreviated | PDF ↗ |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | 2016-08-10 | Traditional | PDF ↗ |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 | Special | PDF ↗ |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 | Special | PDF ↗ |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2016-05-17 | Traditional | PDF ↗ |
| K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | 2016-04-21 | Traditional | PDF ↗ |
| K151742 | Contour Next Control Solution | Bayer Healthcare | 2015-09-23 | Traditional | PDF ↗ |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 | Traditional | PDF ↗ |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | 2015-05-01 | Traditional | PDF ↗ |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics | 2015-04-13 | Traditional | PDF ↗ |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-03-30 | Traditional | PDF ↗ |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-26 | Abbreviated | PDF ↗ |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 | Traditional | PDF ↗ |
| K143680 | ADVIA Centaur IgE Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015-01-27 | Traditional | PDF ↗ |
| K143571 | Audit MicroControls Linearity LQ Cystatin-C | Aalto Scientific, Ltd. | 2015-01-23 | Traditional | PDF ↗ |
| K143639 | IMMULITE 2000 CEA Calibration Verification Material | Siemens Healthcare Diagnostics | 2015-01-23 | Abbreviated | PDF ↗ |
| K143504 | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-01-14 | Traditional | PDF ↗ |
| K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014-12-24 | Abbreviated | PDF ↗ |
| K143376 | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2014-12-23 | Abbreviated | PDF ↗ |
| K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | 2014-12-16 | Traditional | PDF ↗ |
| K143284 | Elecsys Estradiol III Calcheck | Roche Diagnostics | 2014-12-16 | Traditional | PDF ↗ |
| K143194 | ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 | Traditional | PDF ↗ |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity | Aalto Scientific, Ltd. | 2014-11-21 | Traditional | PDF ↗ |
| K142878 | IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014-10-30 | Abbreviated | PDF ↗ |
| K142811 | IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) | Siemens Healthcare Diagnostics, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) | Siemens Healthcare Diagnostics, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K142127 | ELECSYS ESTRADIOL III CALCHECK 5 | Roche Diagnostics | 2014-09-05 | Traditional | PDF ↗ |
| K141772 | IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2014-08-19 | Abbreviated | PDF ↗ |
| K141444 | IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL | Siemens Healthcare Diagnostics, Inc. | 2014-07-09 | Abbreviated | PDF ↗ |
| K133816 | IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2014-06-24 | Traditional | PDF ↗ |
| K140818 | IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C | Siemens Healthcare Diagnostics, Inc. | 2014-05-01 | Abbreviated | PDF ↗ |
| K140541 | IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C | Siemens Healthcare Diagnostics, Inc. | 2014-04-01 | Abbreviated | PDF ↗ |
| K140505 | ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2014-03-31 | Abbreviated | PDF ↗ |
| K140534 | ELECSYS PRECICONTROL TS | Roche Diagnostics | 2014-03-27 | Traditional | PDF ↗ |
| K140267 | ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) | Siemens Healthcare Diagnostics, Inc. | 2014-03-10 | Abbreviated | PDF ↗ |
| K140258 | IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2014-03-05 | Abbreviated | PDF ↗ |
| K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT | Maine Standards Company, LLC | 2014-02-05 | Traditional | PDF ↗ |
| K133197 | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE | Fujirebio Diagnostics,Inc. | 2014-01-17 | Traditional | PDF ↗ |
| K132739 | IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2014-01-14 | Abbreviated | PDF ↗ |
| K133284 | ELECSYS CK-MB CALCHECK 5 | Roche Diagnostics | 2013-11-22 | Traditional | PDF ↗ |
| K133122 | IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) | Siemens Healthcare Diagnostics, Inc. | 2013-10-30 | Abbreviated | PDF ↗ |
| K133124 | IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA | Siemens Healthcare Diagnostics, Inc. | 2013-10-25 | Abbreviated | PDF ↗ |
| K133003 | RIGHTEST CONTROL SOLUTION | Bionime Corporation | 2013-10-24 | Traditional | PDF ↗ |
| K133128 | IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION | Siemens Healthcare Diagnostics, Inc. | 2013-10-22 | Abbreviated | PDF ↗ |
| K131662 | IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2013-10-10 | Abbreviated | PDF ↗ |
| K132391 | IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL | Siemens Helathcare Diagnostics, Inc. | 2013-09-20 | Abbreviated | PDF ↗ |
| K131536 | IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2013-08-12 | Traditional | PDF ↗ |
| K131999 | HBA1C CONTROL, LEVEL 1 AND LEVEL 2 | Randox Laboratories, Ltd. | 2013-07-26 | Traditional | PDF ↗ |
| K131776 | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 | Randox Laboratories, Ltd. | 2013-07-18 | Traditional | PDF ↗ |
| K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 | Maine Standards Co. | 2013-06-14 | Traditional | PDF ↗ |
| K131136 | GLUCOSE METER-CHECK SOLUTION FOR TAIDOC | Bionostics, Inc. | 2013-05-31 | Traditional | PDF ↗ |
| K130764 | AUDIT MICROCV VITAMIN D LINEARITY SET | Aalto Scientific, Ltd. | 2013-04-26 | Traditional | PDF ↗ |
| K130157 | AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET | Aalto Scientific, Ltd. | 2013-03-19 | Traditional | PDF ↗ |
| K122534 | IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | 2013-03-14 | Abbreviated | PDF ↗ |
| K123851 | GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK | Bionostics, Inc. | 2013-02-14 | Traditional | PDF ↗ |
| K123966 | GLUCOSE METER-CHECK SOLUTION FOR BAYER | Bionostics, Inc. | 2013-01-25 | Traditional | PDF ↗ |
| K123612 | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA | Fujirebio Diagnostics,Inc. | 2013-01-17 | Traditional | PDF ↗ |
| K123798 | LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | Bio-Rad Laboratories | 2013-01-09 | Traditional | PDF ↗ |
| K122242 | ELECSYS CA 15-3 II CALCHECK 5 | Roche Diagnostics | 2012-12-05 | Traditional | PDF ↗ |
| K121895 | ELECSYS HSV-2 IGG IMMUNOASSAY | Roche Diagnostics | 2012-08-24 | Traditional | PDF ↗ |
| K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS | Immunodiagnostic Systems , Ltd. | 2012-08-07 | Abbreviated | PDF ↗ |
| K121746 | RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) | Randox Laboratories, Ltd. | 2012-07-11 | Traditional | PDF ↗ |
| K121534 | CONE-TROL HEMOGLOBIN A1C CONTROL SET | Cone Bioproducts | 2012-06-20 | Traditional | PDF ↗ |
| K121588 | RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 | Randox Laboratories, Ltd. | 2012-06-20 | Traditional | PDF ↗ |
| K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE | Cliniqa Corporation | 2012-05-18 | Traditional | PDF ↗ |
| K113177 | COMPLETE D 25-OH VITAMIN D CONTROL | Quantimetrix Corp. | 2012-05-10 | Traditional | PDF ↗ |
| K121279 | ELECSYS LH CALCHECK 5 | Roche Diagnostics | 2012-05-10 | Traditional | PDF ↗ |
| K121084 | LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L | Siemens Healthcare Diagnostics, Inc. | 2012-05-09 | Abbreviated | PDF ↗ |
| K112653 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS | ACON Laboratories, Inc. | 2012-04-09 | Traditional | PDF ↗ |
| K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... | Immunodiagnostic Systems , Ltd. | 2012-02-14 | Abbreviated | PDF ↗ |
| K112143 | AUDIT MICROCV T-UPTAKE LINEARITY | Aalto Scientific, Ltd. | 2012-01-31 | Traditional | PDF ↗ |
| K113764 | GLUCOSE METER-CHECK SOLUTION FOR INFOPIA | Bionostics, Inc. | 2012-01-30 | Traditional | PDF ↗ |
| K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT | Maine Standards Co. | 2012-01-27 | Traditional | PDF ↗ |
| K112352 | GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT | Bionostics, Inc. | 2011-12-23 | Traditional | PDF ↗ |
| K112603 | ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2011-11-04 | Abbreviated | PDF ↗ |
| K112528 | ELECSYS T4 CALCHECK 5 | Roche Diagnostics Corporation | 2011-10-18 | Traditional | PDF ↗ |
| K110061 | CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics | 2011-09-21 | Abbreviated | PDF ↗ |
| K112356 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE | Bionostics, Inc. | 2011-09-19 | Traditional | PDF ↗ |
| K112113 | ELECSYS MYOGLOBIN CALCHECK 5 | Roche Diagnostics | 2011-09-14 | Traditional | PDF ↗ |
| K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... | Immunodiagnostic Systems , Ltd. | 2011-09-06 | Abbreviated | PDF ↗ |
| K112104 | ELECSYS N-MID OSTEOCALCIN CALCHECK 5 | Roche Diagnostics | 2011-08-25 | Traditional | PDF ↗ |
| K111552 | ELECSYS T3 CALCHECK 5 | Roche Diagnostics | 2011-07-21 | Traditional | PDF ↗ |
| K111349 | ELECSYS SHBG CALCHECK 5 | Roche Diagnostics | 2011-06-09 | Traditional | PDF ↗ |
| K110641 | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL | Fujirebio Diagnostics,Inc. | 2011-05-27 | Traditional | PDF ↗ |
| K110613 | ELECSYS PROLACTIN II CALCHECK 5 | Roche Diagnostics | 2011-05-12 | Traditional | PDF ↗ |
| K103744 | DROPPER A1C DIABETES CONTROL | Quantimetrix Corp. | 2011-05-12 | Traditional | PDF ↗ |
| K103683 | IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) | Siemens Healthcare Diagnostics | 2011-04-28 | Abbreviated | PDF ↗ |
| K110436 | FDI GLUCOSE CONTROL SOLUTION FOR AVIVA | Fujirebio Diagnostics,Inc. | 2011-04-20 | Traditional | PDF ↗ |
| K110412 | IDS-ISYS IFG-I CONTROL SET | Immunodiagnostic Systems , Ltd. | 2011-03-16 | Abbreviated | PDF ↗ |
| K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | Bionostics, Inc. | 2011-02-10 | Traditional | PDF ↗ |
| K103450 | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE | Fujirebio Diagnostics,Inc. | 2011-01-25 | Traditional | PDF ↗ |
| K103402 | ELECSYS DHEA-S CALCHECK 5 | Roche Diagnostics | 2011-01-07 | Traditional | PDF ↗ |
| K100715 | AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 | Aalto Scientific, Ltd. | 2010-12-23 | Traditional | PDF ↗ |
| K101427 | AUDIT MICROCV HS-CRP LINEARITY SET | Aalto Scientific, Ltd. | 2010-12-23 | Traditional | PDF ↗ |
| K103099 | PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH | Roche Diagnostics | 2010-12-06 | Traditional | PDF ↗ |
| K102904 | ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL | Siemens Healthcare Diagnostics | 2010-11-23 | Abbreviated | PDF ↗ |
| K103162 | ELECSYS PTH CALCHECK 5 | Roche Diagnostics | 2010-11-18 | Traditional | PDF ↗ |
| K102086 | ELECSYS CA 125 II CALCHECK 5 | Roche Diagnostics | 2010-11-01 | Traditional | PDF ↗ |
Product code JJX · Class I · Clinical Chemistry. Data: openFDA.